| Objective:The purpose of this study is to observe the clinical efficacy and safety of TCM syndrome differentiation and treatment combined with powder in the intervention of chronic gastritis with erosion.The expressions of inflammatory factors interleukin-6(IL-6),tumor necrosis factor-a(TNF-a)and interleukin-10(IL-10)were detected by immunohistochemistry,and TCM syndrome differentiation was obtained.Evidence-based medical evidence for the efficacy and safety of combined powder in intervention of chronic gastritis with erosion.And partially clarify the therapeutic mechanism of traditional Chinese medicine in the treatment of chronic gastritis with erosion.Methods:1.210 outpatients and inpatients diagnosed as chronic gastritis with erosion were selected from Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine,Kunshan Traditional Chinese Medicine Hospital,and Affiliated Hospital of Shanxi College of Traditional Chinese Medicine.They were randomly divided into control group(68 cases)and experimental group(142 cases).The control group was given aluminum-magnesium plus suspension,one bag at a time,three times a day,1 hour after meal;the test group was given traditional Chinese medicine syndrome differentiation+Chinese medicine powder treatment,the decoction one daily,divided into three meals after meals;3g,twice daily,before oral administration.The treatment course of the experimental group and the control group was 4 weeks.2.The western medicine group was given aluminium and magnesium plus suspension,one bag each time,three times a day,one hour after meal;the traditional Chinese medicine group was given traditional Chinese medicine syndrome differentiation and treatment plus traditional Chinese medicine powder treatment,Decoction one dose a day,three times a day after meal;the powder was Sanqi powder,3 g each time,twice a day,orally before meal and dinner.The course of treatment was 4 weeks.3.After the course of treatment,the efficacy and safety of TCM syndrome differentiation and treatment combined with powder in intervening CEG were evaluated from the main therapeutic indicators:improvement of gastric mucosal erosion under gastroscope,histopathological score of gastric mucosa and secondary therapeutic indicators:clinical symptom score and PRO scale score,and adverse events.4.The expression of IL-6,TNF-a and IL-10 in western medicine group and traditional Chinese medicine group were detected by immunohistochemical method before and after treatment.Using US ImageJ V1.8.0 software analysis system,under uniform magnification,the average optical density of IL-6,TNF-a and IL-10 immunohistochemical sections were measured by selecting sections with clear structure and staining,without folding,overlapping and variation.5.All data are expressed as mean(+standard deviation).Statistical analysis software is SAS statistical analysis software version 8.2.The curative effect index is tested by difference.P value less than or equal to 0.05 will be considered to have statistical significance.For demographic data,the basic data of subjects were compared between the two groups.FAS data set was used.2 test,t test or non-parametric statistical method were used for statistical test.The curative effect of traditional Chinese medicine group and Western medicine group was compared.The main efficacy indicators were tested by difference test.The other measurement data were analyzed by variance analysis and non-parametric statistical method with central effect taken into account.Results:1.Actual total income of 210 patients,Chinese medicine group 142 cases,Western medicine group 68 cases,114 males,96 females,Chinese medicine group 79:63 male-female ratio,Western medicine group 35:33 male-female ratio;Chinese medicine group average age 54.15+9.82 years,Western medicine group average age 53.81+8.65 years,the difference was not statistically significant(P>0.05).2.The baseline analysis of each observation index showed that there was no significant difference in the score of gastric mucosal erosion,total score of pathological and histological types of gastric mucosa,clinical symptom score and PRO scale between the traditional Chinese medicine group and the western medicine group at baseline stage(P>0.05),which was comparable.3.Compared before and after treatment,each treatment group can improve gastric mucosal erosion,with statistical significance(P<0.05);after treatment,there was no statistical significance(P>0.05).The healing rate of gastric mucosal erosion was 19.72%,the marked efficiency was 21.13%,the effective rate was 30.28%,the total effective rate was 71.13%,the healing rate of gastric mucosal erosion in western medicine group was 11.76%,the marked efficiency was 22.06%,the effective rate was 35.29%,the total effective rate was 69.12%.The effective rate of improving gastric mucosal erosion in traditional Chinese medicine group was higher than that in western medicine group,but there was no statistical significance(P<0.05).4.Histopathological score of gastric mucosa,before and after treatment,the Western medicine group had statistical significance in improving acute inflammation,chronic inflammation,atrophy and intestinal metaplasia(P<0.05),while the Chinese medicine group had statistical significance in improving chronic inflammation,atrophy,intestinal metaplasia and dysplasia(P<0.05);there was no statistical significance between the two groups after treatment(P>0.05).The effective rate of pathological treatment in gastric mucosa of Chinese medicine group was 23.94%in acute inflammation,28.17%in chronic inflammation,54.23%in atrophy,38.73%in intestinalization,8.45%in dysplasia,29.41%in acute inflammation,23.84%in chronic inflammation,55.88%in atrophy,42.65%in Intestinalization and 5.88%in dysplasia.5.In terms of clinical symptoms,each group can improve the symptoms of patients with statistical significance(P<0.05);in terms of improving the main clinical symptoms and total symptoms such as epigastric pain,epigastric distention,the traditional Chinese medicine group is higher than the western medicine group,with statistical significance(P<0.05);in terms of improving the secondary symptoms such as early satiety,postprandial fullness discomfort,epigastric burning,the traditional Chinese medicine group is slightly higher than the western medicine group,but without statistical significance.Significance(P>0.05).6.The scores of PRO scale were significantly lower in each group before and after treatment(P<0.05).There was no statistical difference between the two groups after treatment(P>0.05).Compared with the difference before and after treatment,the decrease of reflux,dyspepsia,defecation and total score in the traditional Chinese medicine group was better than that in the western medicine group.The difference was statistically significant(P<0.05).There was no significant difference between the general situation,psychological and social comparison groups(P>0.05).7.The expressions of IL-6,TNF-a and IL-10 in gastric mucosa of patients before and after treatment were positive.Compared before and after treatment,the expressions of IL-6,TNF-alpha and IL-10 in each treatment group were decreased,with statistical significance(P<0.05).There was no statistical significance between the two groups after treatment(P>0.05).8.Safety:210 cases were completed in this study.No serious adverse events occurred.After treatment,the incidence of adverse events in traditional Chinese medicine group was lower than that in western medicine group,but there was no statistical difference(P>0.05).Conclusion:1.The traditional Chinese medicine syndrome differentiation and treatment combined with powder has high effectiveness in the treatment of chronic gastritis with erosion,no adverse events occur,and has good safety.2.The pro-inflammatory factors IL-6,TNF-a and anti-inflammatory factor IL-10 are abnormally expressed in gastric mucosal cells of patients with chronic gastritis with erosion.The abnormal expression of inflammatory factors may be the pathogenesis of CEG.3.The clinical efficacy of traditional Chinese medicine syndrome differentiation and treatment combined with powder in the treatment of chronic gastritis with erosion may be achieved by regulating the abnormal expression of IL-6,TNF-a and IL-10. |
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